Associate Director, Medical Data Review

Career Category

Clinical Development

Job Description

JOIN AMGEN'S MISSION OF SERVING PATIENTS

At Amgen, our shared mission - to serve patients living with serious illnesses - drives all that we do. We combine science, technology, and the capabilities of our people to research, develop, and deliver innovative medicines. Our culture is collaborative, inclusive, and science-based, with a strong commitment to integrity, accountability, quality, and continuous learning.

ABOUT THE ROLE

The Associate Director, Medical Data Review leads people, capability, and portfolio delivery for an assigned TA-aligned or adjacent-portfolio group in alignment with CDD priorities. The role ensures that MDR teams have the capacity, skills, controls, and stakeholder support required for high-quality, risk-based delivery.

ROLE DESCRIPTION

This is a people-manager and portfolio-delivery role accountable for people, capacity, portfolio delivery, quality oversight, and escalation. GCF6A owns project/molecule MDR strategy and integrated outputs; GCF5 owns study MDR strategy and delivery unless assigned otherwise; GCF4 performs assigned primary reviews. The Medical Monitor retains accountable medical oversight and medical decisions, while the Clinical Scientist supports study scientific execution. A typical planning span is approximately 12–15 direct reports where portfolio complexity, capability, and coverage needs permit; adjust for risk, workload peaks, or specialized expertise.

ROLES AND RESPONSIBILITIES

·   Lead and develop the MDR team; set clear expectations and maintain a fair, inclusive, accountable, and scientifically rigorous working environment.

·   Own hiring, onboarding, goal setting, performance management, development planning, succession, readiness, recognition, retention, and appropriate performance intervention for direct reports.

·   Translate portfolio demand into transparent capacity and allocation decisions using study complexity, phase, exposure, review strategy, milestone clustering, quality history, and demonstrated capability.

·   Assign and rebalance MDR capacity across studies, projects, molecules, and adjacent therapeutic areas; resolve competing priorities and manage delivery risk.

·   Assure portfolio delivery through oversight of quality, timeliness, milestone readiness, risk escalation, and fit-for-purpose MDR controls without duplicating L6A or L5 technical accountability.

·   Review portfolio-level performance and risk indicators, identify repeated or systemic issues, and sponsor proportionate corrective or capability actions with accountable partners.

·   Ensure that teams provide scientifically strong IDRP contributions and appropriate medical-interpretation inputs to Medical Monitoring Plans through the designated L6A and L5 roles.

·   Lead portfolio adoption of ACT FAST, risk-based review, approved analytics, visualization, and digital capabilities; use evidence to sustain effective practices and stop low-value activity.

·   Build effective relationships with TA/CDD and GDO leaders, Medical Monitors, Clinical Scientists, Medical Monitoring Groups, study teams, Data Management, Safety, Clinical Operations, Biostatistics, Quality, Regulatory, HR, and technology partners.

·   Establish governance and communication cadences for portfolio capacity, delivery health, quality, risks, dependencies, and decisions.

·   Escalate material participant, quality, delivery, compliance, or capacity risks promptly and ensure actions have clear owners and follow-through.

·   Support audit and inspection readiness by ensuring role clarity, consistent practices, and availability of MDR evidence.

·   Use portfolio insights to guide workforce planning, capability development, succession, and future hiring priorities.

·   Responsible for people training, mentoring, and development as per career framework and supporting in individual development plan of each employee, with driving timely feedback

·   Responsible for team’s performance management as per Amgen’s MAP process and calibration.

·   Responsibility for portfolio or program delivery capacity decisions, resource projection and efficient management, quality oversight, and senior stakeholder engagement.

·   Role model Amgen culture and drive the same within the department

·   Responsible for participating in cross functional initiatives, process improvement, driving leadership activities, driving active change management and technology application advancement in MDR process

·   Owns MDR Business Process as assigned and drives operational implementation

·   Drives Scientific discussion (e.g. Journal Club) within TAs and encourage scientific and technical expertise for operation execution and efficiency

STAKEHOLDER RELATIONSHIPS AND ROLE BOUNDARIES

Acts as the MDR portfolio-delivery partner for TA/CDD and GDO leadership and maintains effective links with Medical Monitoring Groups and study teams. The Associate Director assures that the right MDR capability is deployed and that delivery and quality risks are addressed. The role does not take over accountable medical decisions, project/molecule MDR technical strategy, or study MDR strategy from the designated roles.

BASIC QUALIFICATIONS AND EXPERIENCE

·   MD/Diploma with 8-10 years of relevant experience

·   MBBS from an MCI/NMC-recognized medical institution in India with 10-12 years of relevant experience

·   Substantial experience in clinical development, medical data review, medical monitoring, pharmacovigilance, clinical operations, or a closely related regulated environment.

·   Demonstrated readiness to lead people, including evidence of setting expectations, giving feedback, supporting development, planning work, and addressing issues fairly. Prior formal line-management experience is preferred; first-time managers may be considered with a structured transition and support plan.

·   Demonstrated responsibility for portfolio or program delivery, capacity decisions, resource projection and efficient management, quality oversight, and senior stakeholder engagement.

·   Ability to interpret medical-review risks and make fair, evidence-based people and resource decisions.

Placement reflects the breadth of portfolio accountability, leadership scope, complexity, and demonstrated competencies required for the role.

PREFERRED QUALIFICATIONS AND EXPERIENCE

·   MBBS, MD/Diploma, or another relevant medical or clinical qualification.

·   Experience managing medically or scientifically qualified professionals across multiple studies, projects, or therapeutic areas.

·   Experience with RBQM, integrated data review, analytics, Spotfire, digital adoption, and inspection readiness.

·   Experience partnering with Clinical Development, Medical Monitoring, Data Management, Safety, Quality, and HR.

·   Experience leading organizational change, workforce planning, or capability build in a regulated environment.

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